crane feasibility study: nutritional intervention for patients undergoing cancer surgery in low- and middle-income countries

Conditions: Malnutrition; Surgery; Cancer

Summary: aims: the crane feasibility study (a mixed methods study of malnutrition and sustainable nutritional intervention for patients undergoing cancer surgery in low- and middle-income countries) aims to investigate the identification of pre-operative malnourishment, data collection methods and acceptability of a nutritional intervention for a future trial to improve outcomes after cancer surgery in low- and middle-income countries (lmics). 1. to identify and validate the most relevant nutritional screening tool for patients in lmics undergoing surgery for cancer; 2. to identify a low cost sustainable nutritional intervention for patients in lmics undergoing surgery for cancer; 3. to establish the feasibility of delivering a randomised trial of a sustainable nutritional intervention for patients in lmics undergoing surgery for cancer. design: a mixed-methods study comprising of qualitative work including focus groups and interviews, trial of data collection and validation to test feasibility in clinical practice participants: patients undergoing elective surgery for suspected cancer in lmics outcomes work package (wp) 1: the primary deliverable is the identification of a relevant, pragmatic, and acceptable nutritional screening tool. wp 2: the primary deliverable is the identification of a low-cost and sustainable nutritional intervention. focus groups and interviews will be held with patients and clinicians to explore the sustainability, implementation and acceptability of screening and interventions. wp 3: the primary outcome will be to determine feasibility and acceptability of trial design. a number of outcome assessments and data collection instruments will be evaluated for feasibility, including anthropometric parameters and patient outcomes (30-day mortality, major post-operative complications, length of hospital stay and quality of life). a final study design, analysis plan, and health economic plan will be developed. sample size: for this feasibility study, the investigators will conduct multidisciplinary focus groups and interviews, perform and validate malnutrition screening in 200 patients across four countries and record patient 30-day outcomes. this will also include the time taken to collect data on 200 eligible patients. this sample size has been informed from previous malnutrition data originating from a large prospective international multicentre observational cancer study (globalsurg 3).


Eligibility criteria:
inclusion criteria: * hospitals in lmics who undertake planned (elective) cancer surgery for cancer. * patients over 18 years of age (or the age of majority for the country); * patients undergoing planned (elective) surgery for cancer; * patients undergoing surgery where the intent is either curative or palliative; * patients must be able and willing to provide written informed consent (signature or a fingerprint). exclusion criteria: * children (below age of majority for the country); * patients undergoing emergency surgery; * any operative indication other than cancer; * patients unable to provide written informed consent;

Keywords: malnutrition screening tools cancer surgery low and middle-income countries (lmic)